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Maintenance Therapy With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction and Re-induction After Progress for 1st-line Treatment of Metastatic Colorectal Cancer (PanaMa)

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ClinicalTrials.gov Identifier: NCT01991873
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : March 6, 2019
Sponsor:
Collaborators:
ClinAssess GmbH
Amgen
Information provided by (Responsible Party):
AIO-Studien-gGmbH

Brief Summary:

This is a phase II, randomized, multi-center, open-label, parallel-group study to evaluate the progression-free survival during maintenance therapy.

Eligible patients will be treated within a 12-week induction therapy. Those patients achieving CR/PR or SD at 12 weeks and qualifying for maintenance treatment and re-induction treatment with all potential drug components, will be randomized in a ratio of 1:1 to receive chemotherapy plus panitumumab or chemotherapy alone during maintenance. In case of progression, re-induction treatment will be started.


Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Maintenance Chemotherapy Drug: Panitumumab (Within maintenance phase) Drug: mFOLFOX6 (Within re-induction phase) Drug: Panitumumab (Within re-induction phase) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study for Evaluation of Efficacy and Safety of Maintenance Treatment With 5-FU/FA Plus Panitumumab vs. 5-FU/FA Alone After Prior Induction Treatment With mFOLFOX6 Plus Panitumumab and Re-induction With mFOLFOX6 Plus Panitumumab in Case of Progression for First-line Treatment of Patients With Metastatic Colorectal Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Maintenance Chemotherapy + Panitumumab

Maintenance therapy:

Panitumumab 6 mg/kg prior to administration of chemotherapy Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Re-induction upon progression:

Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy.

mFOLFOX6: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Drug: Maintenance Chemotherapy
Other Name: Folinic acid + 5-FU (5-Fluorouracil)

Drug: Panitumumab (Within maintenance phase)
Other Name: Vectibix

Drug: mFOLFOX6 (Within re-induction phase)
Other Name: Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)

Drug: Panitumumab (Within re-induction phase)
Other Name: Vectibix

Experimental: Maintenance Chemotherapy w/o Panitumumab

Maintenance therapy:

Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Re-induction upon progression:

Panitumumab 6 mg/kg prior to administration of mFOLFOX6 chemotherapy.

mFOLFOX6 chemotherapy: Oxaliplatin 85 mg/m2 over 2 hours on day 1 Folinic acid 400 mg/m2 over 2 hours on day 1 5-FU 2400mg/m2 46h continuous infusion day 1 - day 2 Repeat on day 15

Drug: Maintenance Chemotherapy
Other Name: Folinic acid + 5-FU (5-Fluorouracil)

Drug: mFOLFOX6 (Within re-induction phase)
Other Name: Oxaliplatin + Folinic acid + 5-FU (5-Fluorouracil)

Drug: Panitumumab (Within re-induction phase)
Other Name: Vectibix




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Progression-free survival during maintenance therapy defined as time from randomization until disease progression or death, whatever occurs first.


Secondary Outcome Measures :
  1. failure of treatment strategy [ Time Frame: Until end of follow up (24 months after randomization) ]
    Time from randomization until failure (death/ progression) of treatment strategy

  2. Progression-free survival of re-induction [ Time Frame: From start of re-induction therapy until progress or end of follow-up (24 months after randomization) ]
    Progression-free survival during re-induction therapy

  3. Objective response after 12 weeks of induction chemotherapy [ Time Frame: 12 weeks after start of induction chemotherapy ]
    Objective response after 12 weeks of induction chemotherapy

  4. Objective best response during maintenance and re-induction [ Time Frame: Start of maintenance- until end of re-inductin therapy (expected average of 8 months) ]
    Objective best response during maintenance and re-induction

  5. Overall survival [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall survival measured from time of randomization and from time of registration

  6. Safety [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Overall safety

  7. Health and skin related Quality of life [ Time Frame: Until end of follow-up (24 months after randomization) ]
    Health and skin related Quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent
  • Male or female ≥ 18 years of age
  • Histologically proven metastatic colorectal cancer
  • Molecular testing showing RAS wild-type in colorectal carcinoma cells
  • Life expectancy > 12 weeks
  • At least one measurable lesion according to RECIST 1.1
  • Adequate bone marrow, liver, kidney, organ and metabolic function
  • Bone marrow function:

    • leukocyte count ≥ 3.0 × 109/L
    • ANC ≥ 1.5 × 109/L
    • platelet count ≥ 100 × 109/L
    • hemoglobin ≥ 9 g/dL or 5.59 mmol/L (may be transfused or treated with erythropoietin to maintain/ exceed this level)
  • Hepatic function:

    • Total bilirubin ≤ 1.5 × UNL
    • ALT and AST ≤ 2.5 × UNL (or ≤ 5 × UNL in presence of liver metastases)
    • AP ≤ 5 × UNL
  • Renal function:

    • Creatinine clearance ≥ 50 mL/min according to Cockcroft-Gault formula or serum creatinine ≤ 1.5 × UNL
  • Metabolic function:

    • Magnesium ≥ lower limit of normal
    • Calcium ≥ lower limit of normal
  • ECOG performance status 0 - 1
  • Women of child-bearing potential must have a negative pregnancy test

Exclusion Criteria:

  • Previous treatment for colorectal cancer in the metastatic setting
  • Previous EGFR-targeting therapy < 6 months after end of adjuvant therapy
  • Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and steroids
  • Chronic inflammatory bowel disease
  • Peripheral neuropathy ≥ NCI-CTCAE V 4.03 grade 2
  • Other previous malignancies with the exception of a history of previous curatively treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix or other curatively treated malignant disease without recurrence after at least 5 years of follow-up
  • Significant disease that, in the investigator's opinion, would exclude the patient from the study
  • History of cardiac disease; defined as:

    • Congestive heart failure > New York Heart Association (NYHA) class 2
    • Active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
    • Cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted)
    • Uncontrolled hypertension (defined as blood pressure ≥ 160 mmHg systolic and/or ≥ 90 mmHg diastolic on medication)
  • Patients with interstitial lung disease, e.g., pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
  • Known HIV, hepatitis B or C infection
  • Known hypersensitivity reaction to any of the study components
  • Radiotherapy, major surgery or any investigational drug 30 days before registration
  • Pregnancy or lactation or planning to be pregnant during treatment and within 6 months after the end of treatment
  • Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for at least an additional 6 months after the end of treatment
  • Known alcohol or drug abuse
  • Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991873


Contacts
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Contact: Daniela Bein, Dr. d.bein@clinassess.de
Contact: Helge Schröder, Dipl.Biol. Helge.Schroeder@aio-studien-ggmbh.de

Locations
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Germany
St.-Antonius-Hospital Eschweiler Recruiting
Eschweiler, Germany, 52249
Contact: Schlegel, Dr. med.    02403/76-1281      
Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven Not yet recruiting
Wilhelmshaven, Germany, 26389
Contact: Dr. Tanja Trarbach         
Sponsors and Collaborators
AIO-Studien-gGmbH
ClinAssess GmbH
Amgen
Investigators
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Principal Investigator: Tanja Trarbach, Dr. med. Zentrum für Tumorbiologie und Integrative Medizin, Klinikum Wilhelmshaven

Additional Information:
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Responsible Party: AIO-Studien-gGmbH
ClinicalTrials.gov Identifier: NCT01991873     History of Changes
Other Study ID Numbers: AIO-KRK-0212
2012-005422-30 ( EudraCT Number )
PanaMa_DE-2009-0003 ( Other Identifier: Amgen )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

Keywords provided by AIO-Studien-gGmbH:
metastatic colorectal cancer
maintenance therapy
Panitumumab
Vectibix®

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Fluorouracil
Panitumumab
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients